Associate, Project Management (MD)

3 weeks, 2 days ago
Entry Level
Project and Program Management
ClinChoice

ClinChoice

ClinChoice is a leading full-service contract research organization (CRO) that provides high-quality solutions to clients in the pharmaceutical, biotechnology, medical device, and consumer products sectors, focusing on accelerating the development and ...

Professional Services
1K-5K
Founded 1995

Description

  • Own the project management process for Periodic Safety Update Reports (PSURs) and drive process optimization.
  • Deploy and maintain consistent project management methodologies to support PSUR execution.
  • Use medical device quality systems to retrieve documents and route materials for approval.
  • Support audits and inspections related to PSUR processes and reports.
  • Maintain project management tools such as Microsoft Project plans and LeanKit boards.
  • Monitor project milestones and task-level execution to ensure smooth delivery.
  • Provide project management and leadership support to staff.
  • Partner with cross-functional stakeholders including Medical Directors, PSUR, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.
  • Ensure operating company PSUR timelines are met and practices are consistently deployed across the global organization.
  • Track and report metrics for PSURs, CERs, safety surveillance, literature searches, literature reviews, and compliance activities, and support corrective and preventive actions as needed.

Requirements

  • Bachelor’s degree in science or above, aligned with project or business team requirements.
  • 0 to 2 years of relevant experience in the identified functional domain or business workstream.
  • Knowledge of Medical Device Quality Systems.
  • Experience supporting project management activities and tools such as Microsoft Project and LeanKit preferred.
  • Ability to work with cross-functional teams in a regulated environment.

Interested in this position?

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